Boots Gripe Mixture

Children's Gripe Mixture or Gripe Mixture or Infant Sugar Free Gripe Mixture or Children's 1 Month Plus Gripe Mixture or Boots Gripe Mixture 1 Month Plus

Liquid

For the relief of wind and griping pains.

For oral administration.Babies up to 1 month: Not Recommended.Infants 1 - 6 months: 5ml. Infants 6 months - 1 Year: 10ml.The above doses may be repeated before or after each feed up to six times in 24 hours if needed.Not recommended for children over 1 year.

Hypersensitivity to sodium bicarbonate, or any of the ingredients. Metabolic or respiratory alkalosis Hypocalcaemia Hypochlorhydria Patients on low sodium diets Congestive heart failure Oedema/fluid retention Hypertension/eclampsia Impaired renal function Cirrhosis of the liver Aldosteronism Babies under one month of age or over one year of age.

Do not exceed the recommended dose as excess use may lead to alkalosis.This medicine should be given to the child to swallow before or after feeds. Inclusion of this medicine in feeds or bottles has not been studied and should be avoided.Keep all medicines out of the reach of children.

The effect of oral bicarbonate compounds in raising intra-gastric pH may reduce or increase the rate and/or extent of absorption of a number of medicines. Alkalinisation of the urine leads to increased renal clearance of acidic drugs such as salicylates, tetracyclines and barbiturates. Conversely, it prolongs the half life of basic drugs.Sodium bicarbonate enhances lithium excretion.

The safety of sodium bicarbonate during pregnancy and lactation has not been established but its use during these periods is not considered to constitute a hazard.

No adverse effects known

Immune system disorders: Rarely hypersensitivity reactions including skin rashGastrointestinal disorders: Stomach cramps, belching, flatulence, vomitingGeneral disorders and administration site conditions: MalaiseMetabolism and nutrition disorders: Excessive use may lead to hypernatraemia and hyperosmolality, hypokalaemia and metabolic acidosis, especially in patients with impaired renal function

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdosage with this medicine may give rise to the symptoms of hypernatraemia, which may include drowsiness and irritability, pyrexia, tachypnoea and hyperpnoea. In more severe instances of acute sodium overload signs of dehydration and convulsions may occur.Treatment of hypernatraemia includes repair of any dehydration present and the gradual reduction of plasma sodium. The alkalosis, if present, will respond usually to the treatment of hypernatraemia. At all times, intensive monitoring of electrolytes and patient's circulation and central nervous system is essential.

Sodium Bicarbonate has antacid properties.

Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. Any bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline and there is an accompanying diuresis.

Not applicable.

Maltitol liquid GlycerolSodium citrateDomiphen bromideApple flavour 5112O1EPurified waterCarbon dioxide

None stated

24 months unopened12 weeks after opening

Do not store above 25°C.

A clear polythene terephthalate bottle with a polypropylene child resistant closure fitted with an expanded polyethylene liner. Pack size: 150ml

None

The Boots Company Plc1 Thane Road WestNottingham NG2 3AA

PL 00014/5236R

February 2014